Amarin Corporation plc (AMRN - Free Report) announced that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) to approve the label expansion for Vascepa (icosapent ethyl) capsules to reduce cardiovascular risk in patients with persistent elevated triglycerides on statin therapy for LDL-C (bad cholesterol).
Notably, in May, the FDA granted a Priority Review to the supplemental new drug application (sNDA) for Vascepa. The sNDA is seeking approval for the label expansion of Vascepa to include data from the REDUCE-IT cardiovascular outcomes study.
If approved, Vascepa will be the first drug for this indication in the United States. The regulatory body has set an action date of Dec 28, 2019. However, the FDA is not bound by the recommendations of an advisory committee.
We remind investors that, Vascepa is already approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Shares of Amarin have soared 57.9% so far this year compared with the industry's growth of 1.4%.
Vascepa is the only marketed product in Amarin’s portfolio. The drug generated sales of $285.3 million in the first nine months of 2019, reflecting a surge of 88.6% year over year. The drug has seen strong demand and rapid uptake since its approval along with an increase in estimated normalized total prescriptions in the United States.
Potential approval for its label expansion will further boost the sales of the drug. The company is planning to submit a regulatory application seeking approval of Vascepa in Europe before the end of the year and in Canada by the end of 2019 or early 2020.
Meanwhile, Amarin has been actively hiring sales personnel to support the launch of the drug in the expanded label at the start of 2020, upon potential FDA approval.
Key players in Vascepa’s targeted indication are Sanofi (SNY - Free Report) and Amgen’s (AMGN - Free Report) PCSK9 inhibitors, Praluent and Repatha, respectively.
Zacks Rank & Other Key Pick
Amarin is currently a Zacks Rank #2 (Buy) stock. A better-ranked stock in the biotech sector is Anika Therapeutics Inc. (ANIK - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have been revised 16% upward for 2019 and 19.1% for 2020 over the past 60 days. The stock has surged 77.8% so far this year.
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